Actonel Plus Ca & D 35 mg film-coated tablets + 1000 mg/880 IU Effervescent Granules

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Risedronate sodium; Calcium carbonate; Colecalciferol

Dostępny od:

PCO Manufacturing Ltd.

Kod ATC:

M05BB04

INN (International Nazwa):

Risedronate sodium; Calcium carbonate; Colecalciferol

Dawkowanie:

35 mg + 1000 mg/800 international unit(s)

Forma farmaceutyczna:

Effervescent granules + film-coated tablet

Typ recepty:

Product subject to prescription which may be renewed (B)

Dziedzina terapeutyczna:

risedronic acid, calcium and colecalciferol, sequential

Status autoryzacji:

Authorised

Data autoryzacji:

2013-03-08

Ulotka dla pacjenta

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL
® PLUS CA & D
35 mg film-coated tablets + 1000 mg/880 IU effervescent granules
risedronate sodium + calcium/colecalciferol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Actonel Plus Ca & D is and what it is used for
2.
What you need to know before you take Actonel Plus Ca & D
3.
How to take Actonel Plus Ca & D
4.
Possible side effects
5.
How to store Actonel Plus Ca & D
6.
Contents of the pack and other information
1.
WHAT ACTONEL PLUS CA & D IS AND WHAT IT IS USED FOR
WHAT ACTONEL PLUS CA & D IS
A combination medicine containing tablets of Actonel and sachets of
calcium/ vitamin
D
3
.
o
_Actonel tablets _
Actonel tablets contain risedronate sodium which belongs to a group of
non-hormonal
medicines called bisphosphonates.
These medicines are used to treat bone diseases. It works directly on
your bones to
make them stronger and therefore less likely to break.
Bone is a living tissue. Old bone is constantly removed from your
skeleton and
replaced with new bone.
Postmenopausal osteoporosis is a condition occurring in women after
the menopause
where the bones become weaker, more fragile and more likely to break
after a fall or
strain.
The spine, hip and wrist are the most likely bones to break, although
this can happen
to any bone in your body.
Osteoporosis-related fractures can also cause back pain, height loss
and a curved
back. Many patients with osteoporosis have no symptoms and you may not
even
have known that you had i

Charakterystyka produktu

Health Products Regulatory Authority
30 August 2022
CRN00D3YQ
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Plus Ca & D 35 mg film-coated tablets + 1000 mg/880 IU
Effervescent Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35 mg risedronate sodium, (equivalent
to 32.5 mg risedronic acid).
Each sachet of effervescent granules contains 1000 mg calcium (as 2500
mg calcium carbonate) and 22 micrograms (880 IU)
colecalciferol (vitamin D
3
).
Excipients with known effect:
Each film-coated tablet contains lactose monohydrate.
Each sachet of effervescent granules contains potassium, sucrose,
soya-bean oil and sorbitol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
_Product imported from France:_
_Film-coated tablet_
Oval, light-orange, film-coated tablet with RSN on one side and 35 mg
on the other.
_Effervescent granules_
White effervescent granules.
4 CLINICAL PARTICULARS
As per PA22668/002/001
5 PHARMACOLOGICAL PROPERTIES
As per PA22668/002/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Film-coated tablet:
Tablet core:
Lactose monohydrate,
Crospovidone A,
Magnesium stearate.
Cellulose microcrystalline,
Film coating:
Hypromellose,
Macrogol
Hydroxypropylcellulose
Silicon dioxide
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Health Products Regulatory Authority
30 August 2022
CRN00D3YQ
Page 2 of 3
Effervescent granules:
Citric acid anhydrous
Malic acid
Gluconolactone
Maltodextrin
Sodium cyclamate
Saccharin sodium
Sorbitol (E420)
Mannitol (E421)
Dextrin,
Acacia
Natural Lemon oils
Natural Lime flavour
Rice starch,
Potassium carbonate
All-rac-α-Tocopherol
Soya-bean oil, hydrogenated
Gelatin
Sucrose
Maize starch.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the blister, sachet and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does